Vietnam MOH registration 2402638ĐKLH/BYT-HTTB

Cardiac Troponin I (TnI) Quantitative Testing Card

VN: Thẻ xét ngiệm định lượng Troponin I (TnI)

Vietnam·Risk Class TTBYT Loại C·STANDARD™ F TnI FIA·SD Biosensor, Inc.·Registered Sep 30, 2024

Registration details

Analysis ID: 2402638ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-201228-0016
Product Type: STANDARD™ F TnI FIA
Product Code: F-TNI

Company information

Manufacturer: SD Biosensor, Inc.
Manufacturer Country: REPUBLIC OF
Product Owner: SD Biosensor, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH

Technical details

Intended Use: STANDARD™ F TnI FIA is a fluorescent immunoassay for the quantitative determination of the total concentration of cardiac Troponin I (cTnI) in serum and whole blood samples from patients, as performed on the Standard™ F Analyzer manufactured by SD Biosensor. This test is intended for in vitro diagnostic use and is intended to support the screening and monitoring of acute myocardial infarction (AMI).

Dates and status

Registration Date: Sep 30, 2024

About this record

Access comprehensive regulatory information for Cardiac Troponin I (TnI) Quantitative Testing Card in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402638ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.

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